MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number ESBF2514C103E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Hemorrhage/Bleeding (1888)

Event Date 02/07/2022

Event Type  Death  

Manufacturer Narrative

Other relevant device(s) are: product id: etlw1616c82e, serial/lot #: (b)(4), ubd: 21-jan-2023, udi#: (b)(4); product id: etlw1628c124e, serial/lot #: (b)(4), ubd: 29-mar-2023, udi#: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 01-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant iis stent graft system was implanted during an endovascular procedure for the treatment of a 110mm abdominal aortic aneurysm.  it was reported during the index procedure once the stent grafts had been implanted the patient required a blood transfusion (6 units) however expired during the procedure.As per the physician the patients death was as a result of dic blood disorder.The patients blood was not clotting and the patient suffered massive blood loss.  no additional clinical sequalae was provided and the patient has expired.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13512249
• MDR Text Key: 285450449
• Report Number: 9612164-2022-00578
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439986
• UDI-Public: 00643169439986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2022
• Device Model Number: ESBF2514C103E
• Device Catalogue Number: ESBF2514C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/11/2022
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Sex: Male